Registration Dossier
Registration Dossier
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EC number: 224-221-9 | CAS number: 4253-34-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2004-01-12 to 2004-02-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no reliability check reported
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
- Reference substance name:
- Viscous silicon preparation with ca. 4.5% mixture of triacetoxyethylsilane and triacetoxymethylsilane.
- IUPAC Name:
- Viscous silicon preparation with ca. 4.5% mixture of triacetoxyethylsilane and triacetoxymethylsilane.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan GmbH, Borchen, GERMANY
- Age at study initiation: not stated
- Weight at study initiation: 300-500g
- Housing: in groups in Terluran cages
- Diet: standard diet: ad libitum
- Water: drinking water ad libitum
- Acclimation period: described as adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 55 +/-10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12h/ 12h
IN-LIFE DATES: From: To: not stated but within the period 2004-01-12 to 2004-02-13
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% for induction and challenge
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% for induction and challenge
- No. of animals per dose:
- 20 test, 10 controls
- Details on study design:
- RANGE FINDING TESTS: 50% (in corn oil) and 100% tested on 2 animals for irritancy
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Test groups: n=20
- Control group: n=10
- Site: left flank
- Frequency of applications: 3 applications at weekly intervals
- Duration: exposure duration 6h
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the final induction
- Exposure period: 6h
- Test groups: n=20
- Control group: n=10
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48h - Challenge controls:
- Negative but no concurrent positive control or reliability data provided. A reliability check was to be conducted in the future (BSL 040619).
- Positive control substance(s):
- no
- Remarks:
- reliability check was to be conducted in the future (BSL 040619)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- no treatment
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- no treatment
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- other: not included
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- other: not included
Any other information on results incl. tables
No response was recorded at any time point in the test or control groups.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A well conducted, well reported Buehler sensitization test reported that a 100% concentration of the test material failed to induce a sensitization response in guinea pigs when challenged with the same neat test material. Appropriate concurrent negative controls were included, but the positive compliance test was to be undertaken at a later date.
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